Agomelatine Drug Utilisation Study in Selected European Countries: A Multinational, Observational Study to Assess Effectiveness of Risk-Minimisation Measures

Emmanuelle Jacquot,Estelle Collin,Amy Ladner,Anita Tormos,Lynne Hamm,Susana Perez-Gutthann,Lia Gutierrez,Costel Chirila,Nicolas Deltour

Agomelatine Drug Utilisation Study in Selected European Countries: A Multinational, Observational Study to Assess Effectiveness of Risk-Minimisation Measures

2019

Emmanuelle Jacquot
Estelle Collin
Amy Ladner
Anita Tormos
Lynne Hamm
Susana Perez-Gutthann
Lia Gutierrez
Costel Chirila
Nicolas Deltour

Background Hepatotoxic reactions are an important identified risk listed in the agomelatine risk management plan. This post-authorisation safety study evaluated the effectiveness of additional risk-minimisation measures (aRMMs) for agomelatine.

Keywords:

Agomelatine
Multinational corporation
Environmental health
Risk management plan
Drug
Medicine
Observational study
Cohort study
Medical record
Emergency medicine
Liver disease
Blood test
liver function
Regimen

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